If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Lantus Side Effects Reported to FDA

Lantus Side Effect Report#9999313 Cardiac Operation, Hyperglycaemia

This is a report of a 66-year-old male patient (weight: NA) from EG, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Lantus (dosage: NA, start time:

Jan 13, 2014), combined with: NA. and developed a serious reaction and side effect(s): Cardiac Operation, Hyperglycaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lantus treatment in male patients, resulting in Cardiac Operation side effect. The patient was hospitalized.

Lantus Side Effect Report#9995739 Product Quality Issue, Needle Issue

This report suggests a potential Lantus Solostar (insulin Glargine)Product Quality Issue side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Lantus Solostar (insulin Glargine) (dosage: Lot#?4f415a?exp Date?05/01/2016) starting NS. After starting Lantus Solostar (insulin Glargine) the patient began experiencing various side effects, including: Product Quality Issue, Needle IssueAdditional drugs used concurrently:

Vitamins

Although Lantus Solostar (insulin Glargine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Quality Issue, may still occur.

This Dizziness problem was reported by a consumer or non-health professional from US. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On 201311 this consumer started treatment with Lantus Solostar (dosage: Dose:10 Unit(s)). The following drugs were being taken at the same time: NA. When using Lantus Solostar, the patient experienced the following unwanted symptoms/side effects: Dizziness, Weight Decreased, Feeling Abnormal, Blood Glucose Increased, Incorrect Product StorageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dizziness, may become evident only after a product is in use by the general population.

This Nervous System Disorder side effect was reported by a health professional from US. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Lantus (drug dosage: Dose:40 Unit(s)), which was initiated on NS. Concurrently used drugs: NA..After starting to take Lantus the consumer reported adverse symptoms, such as: Nervous System Disorder, Diabetic Gastroparesis, Nausea, Vomiting, Dehydration, HyperglycaemiaThese side effects may potentially be related to Lantus. The patient was hospitalized.

This is a report of a 72-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Lantus Solostar (dosage: Treatment Start Date: 2-3 Years Ago Dose:26 Unit(s), start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Renal Failure Chronic, Blood Glucose Increased, Injection Site Pain, Injection Site Mass after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lantus Solostar treatment in male patients, resulting in Renal Failure Chronic side effect.

Lantus Side Effect Report#9990027 Cardio-respiratory Arrest

This report suggests a potential LantusCardio-respiratory Arrest side effect(s) that can have serious consequences. A 94-year-old female patient (weight: NA) from CO was diagnosed with the following symptoms/conditions: diabetes mellitus and used Lantus (dosage: Dose:5 Unit(s)) starting 2010. After starting Lantus the patient began experiencing various side effects, including: Cardio-respiratory ArrestAdditional drugs used concurrently:

Apidra (1-2-2)

Omeprazole

Acetylsalicylic Acid

Losartan

Metoprolol

Ipratropium Bromide

Acetaminophen

Furosemide

Although Lantus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardio-respiratory Arrest, may still occur.

Lantus Side Effect Report#9989845 Hypoglycaemic Coma

This Hypoglycaemic Coma problem was reported by a health professional from FR. A 86-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On NS this consumer started treatment with Lantus (dosage: NA). The following drugs were being taken at the same time:

Novorapid

Lasilix (Strength: 40 Mg)

Bisoprolol

Temesta

Corvasal

Tahor (Strength: 10 Mg)

Previscan (Strength: 20 Mg)

Veinamitol

When using Lantus, the patient experienced the following unwanted symptoms/side effects: Hypoglycaemic ComaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoglycaemic Coma, may become evident only after a product is in use by the general population.

Lantus Side Effect Report#9989413 Multiple Sclerosis

This Multiple Sclerosis side effect was reported by a consumer or non-health professional from US. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Lantus Solostar (drug dosage: 70 Units), which was initiated on NS. Concurrently used drugs: NA..After starting to take Lantus Solostar the consumer reported adverse symptoms, such as: Multiple SclerosisThese side effects may potentially be related to Lantus Solostar.

This is a report of a 73-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: type 1 diabetes mellitus, who was treated with Lantus (dosage: NA, start time: 2013), combined with:

Apidra Solostar

Solostar

Clikstar

Janumet

Puran T4

Rosuvastatin Calcium

Lasix

Aas

and developed a serious reaction and side effect(s): Diabetic Neuropathy, Condition Aggravated, Local Swelling after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lantus treatment in female patients, resulting in Diabetic Neuropathy side effect. The patient was hospitalized.

This report suggests a potential LantusChronic Hepatitis side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from EG was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Lantus (dosage: NA) starting

Jul 15, 2013. After starting Lantus the patient began experiencing various side effects, including: Chronic Hepatitis, Condition AggravatedAdditional drugs used concurrently: NA. Although Lantus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Chronic Hepatitis, may still occur.

This Blood Pressure Inadequately Controlled problem was reported by a consumer or non-health professional from KR. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On

Jan 28, 2014 this consumer started treatment with Lantus (dosage: Dose:20 Unit(s)). The following drugs were being taken at the same time:

Apidra (Dose:8 Unit(s))

When using Lantus, the patient experienced the following unwanted symptoms/side effects: Blood Pressure Inadequately Controlled, Renal Disorder, Blood Glucose AbnormalThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Pressure Inadequately Controlled, may become evident only after a product is in use by the general population.

Lantus Side Effect Report#9989200 Liver Disorder, Renal Disorder

This Liver Disorder side effect was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 1 diabetes mellitus.The patient was prescribed Lantus Solostar (drug dosage: Dose:25 Unit(s)), which was initiated on 2009. Concurrently used drugs: NA..After starting to take Lantus Solostar the consumer reported adverse symptoms, such as: Liver Disorder, Renal DisorderThese side effects may potentially be related to Lantus Solostar. The patient was hospitalized.

This is a report of a 63-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: type 1 diabetes mellitus, who was treated with Lantus (dosage: Dose:46 Unit(s), start time: NS), combined with:

Insulin (Dose:22 Unit(s))

and developed a serious reaction and side effect(s): Fall, Spinal Fracture, Skin Ulcer, Ischaemia, Blood Glucose Fluctuation, Convulsion, Hypoglycaemia, Aggression, Malaise after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lantus treatment in male patients, resulting in Fall side effect. The patient was hospitalized.

This report suggests a potential LantusDepression side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Lantus (dosage: 2 Units In The Morning And 100 Units At Night.) starting NS. After starting Lantus the patient began experiencing various side effects, including: Depression, Suicidal Ideation, Blood Glucose Increased, StressAdditional drugs used concurrently: NA.The patient was hospitalized. Although Lantus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Depression, may still occur.

This Arthropathy problem was reported by a consumer or non-health professional from US. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On NS this consumer started treatment with Lantus Solostar (dosage: Dose:80 Unit(s)). The following drugs were being taken at the same time: NA. When using Lantus Solostar, the patient experienced the following unwanted symptoms/side effects: Arthropathy, Fall, Paralysis, Abasia, Walking Aid User, Incorrect Product StorageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthropathy, may become evident only after a product is in use by the general population.

This Road Traffic Accident side effect was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Lantus (drug dosage: Dose:10 Unit(s)), which was initiated on NS. Concurrently used drugs: NA..After starting to take Lantus the consumer reported adverse symptoms, such as: Road Traffic Accident, Intervertebral Disc Protrusion, Pain, Back InjuryThese side effects may potentially be related to Lantus.

This is a report of a 82-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Lantus (dosage: 3ml Cartridge?started: Approx. 12 Year, start time: NS), combined with:

Autopen 24

and developed a serious reaction and side effect(s): Femur Fracture, Pain, Arthritis, Bone Erosion, Hypoglycaemia, Apathy, Unresponsive To Stimuli, Hyperhidrosis, Osteoporosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lantus treatment in female patients, resulting in Femur Fracture side effect.

This Urinary Tract Infection problem was reported by a consumer or non-health professional from IL. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On 201401 this consumer started treatment with Lantus (dosage: Dose:16 Unit(s)). The following drugs were being taken at the same time:

Apidra (Dose:6 Unit(s))

Apidra (Dose:10 Unit(s))

When using Lantus, the patient experienced the following unwanted symptoms/side effects: Urinary Tract Infection, Diabetes Mellitus Inadequate Control, Hypoglycaemia, Syncope, Hyperhidrosis, Confusional StateThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Urinary Tract Infection, may become evident only after a product is in use by the general population.

Lantus Side Effect Report#9983661 Cardiac Disorder

This Cardiac Disorder side effect was reported by a consumer or non-health professional from EG. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Lantus (drug dosage: NA), which was initiated on

Jan 13, 2013. Concurrently used drugs: NA..After starting to take Lantus the consumer reported adverse symptoms, such as: Cardiac DisorderThese side effects may potentially be related to Lantus.

Lantus Side Effect Report#9983630 Cerebrovascular Accident

This is a report of a 76-year-old male patient (weight: NA) from EG, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Lantus (dosage: NA, start time:

Jul 09, 2013), combined with: NA. and developed a serious reaction and side effect(s): Cerebrovascular Accident after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lantus treatment in male patients, resulting in Cerebrovascular Accident side effect.

Lantus Side Effect Report#9983497 Musculoskeletal Discomfort, Malaise

This report suggests a potential Lantus SolostarMusculoskeletal Discomfort side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Lantus Solostar (dosage: Dose:35 Unit(s)) starting NS. After starting Lantus Solostar the patient began experiencing various side effects, including: Musculoskeletal Discomfort, MalaiseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Lantus Solostar demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Musculoskeletal Discomfort, may still occur.

This Glaucoma problem was reported by a consumer or non-health professional from US. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On 2005 this consumer started treatment with Lantus Solostar (dosage: Dose:32 Unit(s)). The following drugs were being taken at the same time:

Metformin

When using Lantus Solostar, the patient experienced the following unwanted symptoms/side effects: Glaucoma, Retinal Vascular Disorder, Cataract, Eye Haemorrhage, Lipodystrophy Acquired, Oedema, Rash, Weight Increased, PruritusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Glaucoma, may become evident only after a product is in use by the general population.

This Cardiac Disorder side effect was reported by a consumer or non-health professional from US. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Lantus Solostar (drug dosage: Product Start Date- 1 Year?frequency- Once A Day Dose:8 Unit(s)), which was initiated on NS. Concurrently used drugs: NA..After starting to take Lantus Solostar the consumer reported adverse symptoms, such as: Cardiac Disorder, Blood Glucose IncreasedThese side effects may potentially be related to Lantus Solostar. The patient was hospitalized.

This is a report of a 72-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Lantus Solostar (dosage: From; 3 And Half Year., start time: NS), combined with:

Novolog

and developed a serious reaction and side effect(s): Cerebrovascular Accident, Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lantus Solostar treatment in female patients, resulting in Cerebrovascular Accident side effect. The patient was hospitalized.

The appearance of Lantus on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Search for drug prescribing information: overdose risks, side effects, adverse reactions, and more

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

You can use them to remind you of details that may alert your health care professional(s) to a problem

You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

Log Form

You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

Medicine Name and Dosage:

Side Effects

Scale

Date & Time

Other Medicine(s) or Treatment(s)

Scale: 1 = very mild to 10 = very bad

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Lantus reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

Lantus (insulin glargine)

Audience - Diabetes healthcare professionals, patients

[UPDATED 01/12/2011] FDA has reviewed studies and determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis. These limitations prevent ability to attribute the observed cancer risk to Lantus.

At this time, FDA has not concluded that Lantus increases the risk of cancer. FDA's review is ongoing, including review of information from a current clinical trial, and the Agency will update the public when it has additional information.

Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Lantus.

[Posted 07/01/2009] FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.

FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.

The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program.

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